Asuncion

Researchers are evaluating the safety and effectiveness of the PerQdisc Nucleus Replacement Device NRD for patients with degenerative disc disease DDD causing chronic low back pain. This prospective, open-label, multi-center study involves 72 patients who have DDD in one or more lumbar discs between L1 and S1. The study aims to collect additional data on this minimally invasive device, which is designed to maintain disc height and preserve spinal motion compared to the current standard spinal fusion surgery. Participants will undergo nucleus replacement surgery using the PerQdisc device via standard anterior, lateral, or minimally invasive posterolateral surgical approaches to replace the single nucleus pulposus in the affected lumbar disc. All surgeries require approval from a Medical Advisory Board. The study focuses on patients who have exhausted at least six months of conservative treatments for their back pain and meet specific criteria, including disc height and pain scores. During the study, participants will be monitored closely with evaluations at multiple time points up to five years. Researchers will assess performance outcomes such as disability Oswestry Disability Index, pain levels Visual Analog Scale, disc height, and range of motion, as well as safety outcomes including device expulsion, failure, neurological status, revision surgeries, and serious adverse events. Follow-up visits will include questionnaires, imaging, and clinical assessments to track the devices impact over time.

Researchers are evaluating the safety and performance of the Neurotronic Infusion Catheter in treating adults with Type 2 Diabetes Mellitus T2DM and hypertension, conditions often accompanied by obesity. This prospective, single-arm, multi-center trial aims to study chemical denervation of renal and hepatic arteries to understand potential benefits for these patients. The study is sponsored by Neurotronic, Inc. and is conducted as a Phase 1 trial. Participants receive treatment using the Neurotronic Infusion Catheter, which delivers ethanol ablation to the renal and common hepatic arteries. This procedure aims to chemically denervate these arteries to address T2DM and hypertension. The trial involves a single treatment group undergoing this ablation procedure. During the study, participants will be closely monitored for safety and device performance starting immediately during the procedure and continuing for 30 days after. Follow-up assessments will evaluate glycemic and hypertension control at multiple time points, including 1, 3, 6, 12, and 24 months, with optional extended follow-ups up to 5 years. Researchers will collect data on serious device- and procedure-related complications, treatment success, and long-term health outcomes over the course of participation, which may extend up to several years.

Researchers are studying Latin American adults diagnosed with moderate to severe obstructive sleep apnea OSA to better understand the characteristics of their upper airway and how they respond to a neuromodulation therapy. This early phase 1 study aims to compare responses in this population to previous studies conducted in the U.S., focusing on detailed airway assessments to evaluate the therapys potential. Participants will undergo an overnight sleep study polysomnography followed by a drug-induced sleep endoscopy DISE procedure with phrenic nerve stimulation PNS during a 30-minute research period. The study uses VOTE scoring to classify the type of upper airway collapse and to assess how the neuromodulation treatment affects airway opening and its connection to patient characteristics. During the study, participants will be evaluated from enrollment to study exit, usually within three weeks of screening. Researchers will review sleep study data, airway collapse patterns, and response to nerve stimulation. The main outcome measures include response differences compared to U.S. data, airway collapse characterization via VOTE scoring, and the effect of phrenic nerve stimulation on OSA. Safety and treatment viability are monitored throughout the study period.

Researchers are evaluating the effects of tirzepatide on adults with obesity and adults with type 2 diabetes mellitus T2DM in Paraguay. This study aims to assess how well tirzepatide works and how safe and tolerable it is in real-world conditions, considering the unique genetics, diet, and lifestyle of the Paraguayan population. The study includes two groups one with obesity but no diabetes, and one with T2DM with or without obesity. All participants will receive tirzepatide injections once a week, starting at 2.5 mg with doses increased every 4 weeks as tolerated, following a standard schedule. Along with medication, participants will follow a high-protein, low-carbohydrate diet and a structured exercise plan to support weight loss and metabolic health. The study lasts 52 weeks, with visits approximately every 6 weeks, including evaluations like body composition, ultrasounds, muscle strength, and lab tests. Participants will be monitored closely for changes in body weight, HbA1c levels, and any side effects throughout the year. Body fat and muscle mass will be measured using bioelectrical impedance, and ultrasound scans of the abdomen and thyroid will be done at the start, halfway point, and end of the study. Safety is carefully tracked, especially for gastrointestinal and liver-related issues. The study excludes people using insulin to focus on tirzepatides effects as a primary treatment option.

Researchers are evaluating the safety and feasibility of the Tioga TMVR System for treating patients with symptomatic mitral regurgitation MR of moderate to severe degree MR 3. This prospective, single-arm, multi-center study plans to enroll up to 30 patients, focusing on those who are not ideal candidates for surgical intervention or other treatments. The Tioga TMVR System is designed to replace the native mitral valve through a minimally invasive, percutaneous transseptal approach. The investigational device involves implanting a bioprosthetic mitral valve via transfemoral-transseptal access to replace the diseased valve. All participants receive treatment with the Tioga TMVR System as part of a single study group. The study includes the index procedure on Day 0 and monitors participants closely for safety and performance outcomes during the early post-procedure period. Participants will undergo follow-up visits to assess safety up to 30 days after the procedure and performance outcomes immediately after the valve replacement. Researchers will monitor heart function and related health parameters, track any adverse events, and evaluate how well the device works in replacing the mitral valve. The total study duration includes initial treatment and follow-up assessments to ensure thorough evaluation of the devices use in this patient population.

Researchers are evaluating the Lunair Alpha System, a neurostimulator device, for its safety and effectiveness in treating moderate to severe sleep disordered breathing, including sleep apnea. This is the first human study of this device, aiming to address treatment challenges for patients who cannot tolerate or comply with existing therapies. The study involves implanting the Lunair Alpha System neurostimulator in participants diagnosed with moderate to severe sleep disordered breathing confirmed by polysomnography PSG. There are no placebo groups or blinding. Participants will be monitored for adverse events from enrollment through 12 months after implant. Secondary outcomes include improvements in sleep disordered breathing assessed by sleep studies at 6, 12, and 24 months post-implant. Participants will undergo evaluations including PSG sleep studies to monitor breathing patterns and safety assessments for device- or procedure-related adverse events. Researchers will track changes in breathing during sleep and overall sleep quality over two years. The total study duration includes long-term follow-up to evaluate sustained safety and effectiveness of the implanted neurostimulator device.

This trial evaluates the safety and technical success of the Tangent Tricuspid Annular Therapy System in patients with severe, symptomatic functional tricuspid regurgitation. The study focuses on patients who have this condition despite optimal medical therapy and aims to assess device-related major adverse events and technical efficacy. Participants will receive the experimental Tangent device designed for transcatheter tricuspid valve repair. The study is single-arm and prospective, with safety and technical performance measured during and after the procedure, including hospital discharge assessments. Participants will undergo follow-up visits at 30 days, 90 days, 180 days, and 365 days post-procedure. During these visits, researchers will assess safety endpoints, technical success, functional class, quality of life, walking ability, and tricuspid regurgitation severity. The total participation may last up to one year after the procedure, with careful monitoring of outcomes and device performance.

Researchers are evaluating the safety and performance of the STARgraft 10401 hemodialysis access graft in patients with End Stage Renal Disease ESRD who require hemodialysis through a prosthetic vascular graft. This single-site, prospective, single-arm study compares the investigational STARgraft with prior ePTFE controls and published data over a 6-month period, with potential additional data collection extending to 36 months post-implantation. Participants will receive a 6mm diameter STARgraft 10401 device implanted as an upper arm Brachial Artery to Axillary Vein shunt to provide vascular access for hemodialysis. The study focuses on evaluating the devices effectiveness and safety within this treatment setup, with no comparator arm in this single-arm design. During the study, participants will be monitored for primary unassisted patency and serious device-related adverse events at 6 months, along with longer-term assessments up to 36 months including assisted patency, graft infections, major events, and additional safety measures. These evaluations involve clinical follow-up visits and safety monitoring, with total participation potentially lasting up to three years after graft implantation.